Monoclonal antibodies which identify the glycoprotein carrying the CA 125 epitope

Abstract

Hybridomally produced monoclonal antibodies specifically immunoreactive with the glycoprotein carrying the CA 125 epitope. Monoclonal antibodies recognize both high and low molecular weight subunits of the antigen, and identify the antigen in the cytoplasm and the extracellular matrix of CA 125 producing cells. An immunoassay for the detection of CA 125 utilizing the monoclonal antibodies is described.

I claim: 
     
       1. An immunoassay method for detecting the presence of CA 125 antigen in a test specimen comprising the steps of: providing a test specimen suspected of containing CA 125 antigen;   contacting the test specimen with murine monoclonal antibody M11 under conditions permitting M11 to specifically bind with any CA 125 antigen present in the test specimen; and   thereafter, determining the presence of M11 bound to the test specimen to thereby indicate the respective presence of CA 125 antigen in the test specimen.   
     
     
       2. A method as defined in claim 1, wherein in said determining step the presence of bound M11 is determined by removing any unbound M11 from the test specimen and then contacting the test specimen with a labeled anti-mouse antibody under conditions sufficient to permit the labeled antibody to bind with any M11 bound to the test specimen; removing any unbound labeled antibody; and   thereafter, determining the presence of bound labeled antibody in the test specimen.   
     
     
       3. A method as defined in claim 2, wherein the labelled anti-mouse antibody is an enzyme-labelled anti-mouse antibody. 
     
     
       4. A immunoassay method for detecting the presence of CA 125 antigen in a test specimen, comprising the steps of: providing a solid phase having a first antibody thereon, said first antibody being selected from the group consisting of OC 125 and murine monoclonal antibody M11;   contacting a test specimen suspected of containing CA 125 antigen with said solid phase under conditions permitting any CA 125 antigen present in the sample to bind to the first antibody;   contacting the solid phase with a labeled antibody different from the first antibody and selected from the group consisting of labeled OC 125 and murine monoclonal antibody M11, and if murine monoclonal antibody M11 is used as the antibody different from the first antibody, further contacting with labeled anti-mouse antibody;   removing any unbound labeled antibody from the solid phase; and   thereafter, detecting the presence of any labeled antibody bound to the solid phase to indicate the respective presence of CA 125 antigen in the test specimen.